The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Circapak Universal Volume Ventilator Circuit.
Device ID | K861555 |
510k Number | K861555 |
Device Name: | CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004 |
Contact | Wilke |
Correspondent | Wilke RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-25 |
Decision Date | 1986-06-05 |